System and method for maintaining, monitoring and/or improving air quality and purity in at least one room or environment

ABSTRACT

A system and method for maintaining, monitoring and improving air quality and purity in a room or environment, such as a hospital room or operating room.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation of U.S. Application Serial No.15/923,096 filed Mar. 16, 2018, which claims priority to provisionalU.S. Application Serial No. 62/472,822, filed Mar. 17, 2017, to whichApplicant claims the benefit of the earlier filing date. Theseapplications are incorporated herein by reference and made a parthereof.

BACKGROUND OF THE INVENTION 1. Field of the Invention

This invention relates to a system and method for maintaining,monitoring and improving air quality and purity in a room orenvironment, such as a hospital room or operating room.

2. Description of the Related Art

The increasing prevalence of drug resistant pathogens has increasedinterest in environmental elimination of pathogens, particularly inhealth care settings. Several inventions have made claims to eliminatingpathogens in these settings. One area of concern is the operating room,where surgical site infections have led to significant human andeconomic costs. Typically, air quality in operating room settings hasrelied on fixed ventilation systems which provide various rates of airexchange and positive room pressure. However, such systems may not beadequate for evolving needs of surgical procedures. High room traffic,equipment, and multiple procedure turnovers per day have increasedairborne bioload, necessitating additional air purification capacity inmany operating rooms. This is particularly true with the increased useof surgical implants, which are susceptible to bacterial colonization.

The use of portable HEPA filters and recirculating devices in theoperating room has been described. However, these units are notappropriate for operating room use because the units and/or their intakefilters can become contaminated with infectious biological debris. Thiscan spread contamination from one procedure to the next.

Another problem with the prior art is the collection, assimilation andunderstanding of data associated with a patient, the patient’sassociated clinical data and the actual physical parameters of theoperating room in which the patient may undergo a procedure. In thepast, an operating room was typically scheduled and used withoutmeasurements of air contamination or evaluation of the physical dataassociated with the operating room, the patient and the air quality inthe operating room.

Still another problem with the prior art is that very little, if any,research and information could be gathered or conducted which comparedor correlated air quality and contamination levels in a room, such as anoperating room, with information relating to at least one or a pluralityof patients so that correlations could be made between, for example,infection rates of patients who underwent a common surgical procedure.

What is therefore needed is a method to purify operating room air whichallows each surgical procedure to have a non-contaminated air purifierto prevent the spread of bacterial contamination.

SUMMARY OF THE INVENTION

It is, therefore, one object of the invention to provide a system andmethod for improving air quality in a room or environment, such as ahospital room or operating room.

Another object of the invention is to provide a system and method whichis adapted to gather and collect clinical and physical data andparameters associated with a patient and also physical data andparameters associated with at least one room or environment where thepatient is located.

Another object of the invention is to provide a system and method forcollecting information for evaluation and study in order to improve airquality in a room or environment.

Still another object of the invention is to provide a system and methodthat either automatically or manually evaluates and/or correlatespatient data with physical data and parameters for a room or environmentand performs at least one or a plurality of actions in response thereto.

Still another object of the invention is to provide for an inventory anddata collection system that is adapted to evaluate at least one ofclinical and physical data and parameters for a patient and physicaldata and parameters for a room, such as an operating room and form atleast one or a plurality of the following actions:

-   Research (e.g., infection rates versus room air quality)-   Air quality control-   Room contamination evaluation and remediation-   Air purifier monitoring-   Air cleaning element quality-   Air cleaning element reorder-   Air cleaning element replacement-   Air cleaning element cleaning-   Room condition sensing    -   Temperature    -   Humidity    -   Air quality-   Record retention of air quality and room conditions-   Alarm-   Investigation of issues

Yet another object of the invention is to provide a system and methodfor automatically reordering at least one cleaning element in responseto at least one of clinical and physical data and parameters associatedwith a patient or physical data and parameters associated with a room.

Yet another object of the invention is to provide a system and methodthat correlates air quality in a room or environment with clinical data,such as clinical procedure and/or infection rates.

Another object of the invention is to provide a system and method thatgives a complete picture of clinical and physical data for a patient androom, respectively, and identifies areas of concern or issues.

In one aspect, one embodiment of the invention comprises a system formaintaining or monitoring at least one environment having at least oneair purifier, the system comprising at least one first input or inputmeans for a user to input at least one of clinical data or physicalparameters into a collection system, at least one second input or sensorassociated with the environment for collecting physical data regardingthe environment and for inputting it into the collection system, atleast one output for outputting the at least one of clinical or physicalparameters and the physical data, at least one element that uses andprocesses the at least one of clinical or physical parameters and thephysical data in a predetermined format as input from the at least onefirst input and the at least one second input, respectively, and outputsintegrated information, and the system being adapted to permit a user touse such integrated information to at least one of maintain or improvethe at least one of the environment or take at least one action inresponse to the integrated information, the integrated information beingadapted or used for at least one of research, improving air quality,quality review of the environment or control or notification of at leastone issue associated with the environment or the integrated information.

In another aspect, another embodiment of the invention comprises asystem for improving air quality in at least one hospital room oroperating room, the system comprising at least one first input or sensorfor inputting for a user to input at least one of clinical data orphysical parameters into a collection system, at least one second inputor sensor associated with an environment for collecting physical dataregarding the environment and for inputting it into the collectionsystem, at least one output for outputting the at least one of clinicalor physical parameters and the physical data, at least one element thatuses and processes the at least one of clinical or physical parametersand the physical data as input from the at least one first input and theat least one second input, respectively, and outputs integratedinformation, and the system being adapted to permit use of suchintegrated information to take at least one action that at least one ofmaintains or improves the air quality.

In still another aspect, another embodiment of the invention comprises amethod for maintaining or monitoring at least one environment having atleast one air purifier, the method comprising the steps of inputting atleast one clinical data or physical parameters into a collection system,sensing physical data regarding the at least one environment and forinputting it into the collection system, outputting from the collectionsystem at least one output generated using the at least one of clinicalor physical parameters and the physical data, using at least one elementto process the at least one of clinical or physical parameters and thephysical data as input from at least one first input and at least onesecond input, respectively, and outputs integrated information inresponse thereto, and using such integrated information to at least oneof maintain or improve the at least one of the environment or take atleast one action in response to the integrated information, theintegrated information being adapted or used for at least one ofresearch, improving air quality, quality review of the environment orcontrol or notification of at least one issue associated with theenvironment or the integrated information.

In still another aspect, another embodiment of the invention comprisesan inventory system for supporting the purifying of operating room airon a per-patient basis consisting of a record of patient identifyinginformation, a record describing an air cleaning element utilized in anair purifier located in an operating room, the air cleaning elementbeing used for an individual patient procedure, the record describingthe air cleaning element comprising manufacturer name, part number,and/or serial number in association with the patient identifyinginformation, the inventory system adapted to facilitate inventoryactions such as re-ordering, replacement, recordkeeping, invoicingand/or billing of the air cleaning element, the inventory systemassociating the inventory actions to the patient identifyinginformation.

In still another aspect, another embodiment of the invention comprises amethod of purifying operating room air comprising activating a portableair purifier, after a surgical procedure, removing a contaminated aircleaning element from the air purifier, recording data regarding the aircleaning element to effect remuneration or recordkeeping by hospital,air cleaning element manufacturer, patient, or related payor inelectronic or paper medical record or related document, replacing theair cleaning element with new air cleaning element.

In still another aspect, another embodiment of the invention comprises amethod of purifying operating room air comprising locating an area of anoperating room which has the highest amount of human traffic/and orairborne contamination, positioning an air purifier proximate to thearea, the air purifier having an air cleaning element, after a surgicalprocedure, removing a contaminated air cleaning element from the airpurifier, recording data regarding the air cleaning element to effectremuneration or recordkeeping by hospital, air cleaning elementmanufacturer, patient, or related payor in electronic or paper medicalrecord or related document, replacing the air cleaning element with anew air cleaning element.

In still another aspect, another embodiment of the invention comprises amethod of purifying operating room air comprising positioning an airpurifier adjacent to an operating room door, instrument table or patienttable, the air purifier having an air cleaning element, after a surgicalprocedure, removing a contaminated air cleaning element from the airpurifier, recording data regarding the air cleaning element to effectremuneration or recordkeeping by hospital, air cleaning elementmanufacturer, patient, or related payor in electronic or paper medicalrecord or related document, replacing the air cleaning element with newair cleaning element.

In still another aspect, another embodiment of the invention comprises amethod of purifying operating room air comprising placing an airpurifier, the air purifier having means for direct bacterialdeactivation, such as irradiation, chemical oxidation, or ionization,and an air cleaning element, after a surgical procedure, removing acontaminated air cleaning element from the air purifier, recording dataregarding the air cleaning element to effect remuneration orrecordkeeping by hospital, air cleaning element manufacturer, patient,or related payor in electronic or paper medical record or relateddocument, replacing the air cleaning element with new air cleaningelement.

In still another aspect, another embodiment of the invention comprises amethod of purifying operating room air comprising placing an airpurifier, the air purifier having means for air quality monitoring andan air cleaning element, after a surgical procedure, removing acontaminated air cleaning element from the air purifier, recording dataregarding the air cleaning element to effect remuneration orrecordkeeping by hospital, air cleaning element manufacturer, patient,or related payor in electronic or paper medical record or relateddocument, recording data regarding air quality information in a patientrecord or related record, replacing the air cleaning element with newair cleaning element.

In still another aspect, another embodiment of the invention comprises amethod for providing an air purifier for operating room use, thepurifier provided to the hospital or surgical facility at no cost or formaterially less than the typical purchase cost of comparable product,the purifier containing an interchangeable air cleaning element, the aircleaning element changed on a per patient basis, the hospital orsurgical facility, patient, payor or related party, paying for the aircleaning element on a per-patient basis, revenue from the air cleaningelement usage offsetting cost of the purifier.

In still another aspect, another embodiment of the invention comprisesan inventory and data collection system, operative with an airpurification device, for the purpose of recording and integration ofdata regarding physical parameters and clinical parameters within aclinical situation.

This invention, including all embodiments shown and described herein,could be used alone or together and/or in combination with one or moreof the features covered by one or more of the following list offeatures:

-   The system wherein the at least one action is a service of the air    purifier.-   The system wherein the service is changing an air cleaning element    in the air purifier.-   The system wherein the at least one action is automatically    controlling operation of the air purifier in the at least one    environment in response to the integrated information.-   The system wherein the at least one action is using the integrated    information for at least one of research, evaluation of air    particulate levels, or providing a condition of the at least one    environment.-   The system wherein the condition of the at least one environment is    at least one of air particulate level, contamination level,    cleanliness, temperature, humidity or air quality.-   The system wherein the at least one environment is a room where a    patient is located.-   The system wherein the at least one environment is an operating    room.-   The system wherein the clinical data is at least one of patient    information and/or identification codes, diagnosis, location    identification, clinical event type, clinical event length or    clinical event time.-   The system wherein the physical data is at least one of air    particulate levels, air quality, temperature, humidity, air purifier    functionality, ultraviolet output, air cleaning element condition,    air cleaning element identification codes or air purifier    identification codes.-   The system wherein the at least one action is a service of an air    purifier.-   The system wherein the service is re-ordering a replacement air    cleaning element for the air purifier.-   The system wherein the service is changing an air cleaning element    in the air purifier.-   The system wherein the at least one action is automatically    controlling operation of an air purifier in the at least one    hospital room or operating room in response to the integrated    information.-   The system wherein the at least one action is using the integrated    information for at least one of research, evaluation of air    particulate levels, or providing a condition of the at least one    hospital room or operating room.-   The system wherein the condition of the at least one hospital room    or operating room is at least one of air particulate level,    contamination level, cleanliness, temperature, humidity or air    quality.-   The system wherein the clinical data is at least one of patient    information and/or identification codes, diagnosis, location    identification, clinical event type, clinical event length or    clinical event time.-   The system wherein the physical data is at least one of air    particulate levels, air quality, temperature, humidity, air purifier    functionality, ultraviolet output, air cleaning element condition,    air cleaning element identification codes or air purifier    identification codes.-   The system wherein said at least one action includes at least one of    research, air quality control, room contamination evaluation and    remediation, air purifier monitoring, air cleaning element quality,    air cleaning element reorder, air cleaning element replacement, air    cleaning element cleaning, room condition sensing temperature,    humidity and/or air quality, record retention of air quality and    room conditions, alarm and/or investigation of issues.-   The system wherein the at least one sensor comprises at least one of    an air particle sensor, an optical sensor, an internal pressure    sensor, a humidity sensory and/or a temperature sensor.-   The system wherein the air cleaning element may be one of an air    filter, an electrostatic screen, an ultraviolet light or the like.-   The method wherein the at least one action is a service of the air    purifier.-   The method wherein the method comprises the step of changing an air    cleaning element in the air purifier in response to the integrated    information.-   The method wherein the method further comprises the step of    automatically controlling operation of the air purifier in the at    least one environment in response to the integrated information.-   The method wherein the method further comprises the step of using    the integrated information for at least one of research, evaluation    of air particulate levels, or providing a condition of the at least    one environment.-   The method wherein the condition of the at least one environment is    at least one of air particulate level, contamination level,    cleanliness, temperature, humidity or air quality.-   The method wherein the at least one environment is a room where a    patient is located.-   The method wherein the at least one environment is an operating    room.-   The method wherein the clinical data is at least one of patient    information and/or identification codes, diagnosis, location    identification, clinical event type, clinical event length or    clinical event time.-   The method wherein the physical data is at least one of air    particulate levels, air quality, temperature, humidity, air purifier    functionality, ultraviolet output, air cleaning element condition,    air cleaning element identification codes or air purifier    identification codes.-   The inventory and data collection system wherein the clinical    situation is a surgical procedure.-   The inventory and data collection system wherein the clinical    parameters include at least one of patient information and/or    identification codes, diagnosis, location identification, clinical    event type, clinical event length, clinical event time.-   The inventory and data collection system wherein the physical    parameters include at least one of air particulate levels, air    quality, temperature, humidity, air purifier functionality,    ultraviolet output, air cleaning element condition, air cleaning    element identification codes or air purifier identification codes.-   The inventory and data collection system wherein the integration    comprises a means to record and/or display the clinical and physical    parameters substantially contemporaneously to allow for a user to    readily evaluate the relationship between the parameters.-   The inventory and data collection system wherein the system    incorporates an input means to allow for automatic and/or user input    of the clinical and physical parameters, the input means    incorporating at least one of sensors, keyboard, touchscreen, remote    signal, radiofrequency identification, or similar means.-   The inventory and data collection system wherein the system    incorporates an output means to allow for user monitoring of the    clinical and physical parameters, the output means consisting of    visual, printed, or electronic outputs for local or remote    monitoring.-   The inventory and data collection system wherein the system    incorporates a storage means to allow for storage of the clinical    and physical parameters, the storage means consisting of magnetic,    solid state, cloud, or other equivalent data storage methodologies    operating at a local or remote location.

These and other objects and advantages of the invention will be apparentfrom the following description, the accompanying drawings and theappended claims.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

FIG. 1 is a view of a system in accordance with one embodiment of theinvention;

FIG. 2 is a schematic diagram of the process or method in accordancewith an embodiment of the invention; and

FIG. 3 is a schematic view of an air particulate sensor in accordancewith one embodiment of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to FIGS. 1 and 2 , a system 10 and method for maintaining,monitoring and improving air quality and purity in at least one room orenvironment 12 is shown. As a general overview, the system 10 and methodbeing described is adapted and/or used in association with the at leastone room or environment 12. In one embodiment, the at least one room orenvironment 12 is a room in a hospital, such as a patient room or anoperating room where a patient P is located. As mentioned earlier, oneobject or goal of the invention is to maintain, monitor and/or improvethe air quality in the at least one room or environment 12.

In the illustration being described, the system 10 comprises an airpurifier 14 of the type available from Aerobiotix, Inc. of Dayton, Ohio.One or more of the air purifiers or features of the air purifiers shownin the following U.S. Patents, which are owned by the Assignee of thepresent application, all of which are incorporated herein by referenceand made a part hereof, may be used or adapted for use in the system 10:U.S. Pat. Nos. 9,433,693; 9,457,119; 9,764,054 and U.S. Pat. PublicationNos. 2016/0263267 and 2017/0296691. The air purifier 14 comprises areplaceable air filter or air cleaning element 16. The air cleaningelement 16 may be a Model No. PL-1 available from Aerobiotix, Inc. ofDayton, Ohio. It should be understood that the air cleaning element 16may be an air filter, an electrostatic screen, an ultraviolet light, orthe like.

In general, it is desirable to replace the air cleaning element 16 afterit has been exposed to airborne contaminants in the air purifier 14,especially before a surgical or other procedure. For example, it isdesirable not to replace the air cleaning element 16 prematurely (e.g.,when it is not contaminated or dirty) or early in order to avoid thecost, and it is also desirable not to replace the air cleaning elementtoo late when it becomes less effective with filtering airbornecontaminants that pass through the air purifier 14. The air cleaningelement 16 may be replaced based upon one or more variables, which mayinclude time elapsed or number of procedures performed. The system 10may comprise an internal clock (not shown) which is reset upon the aircleaning element 16 being changed or entry of specific procedures intothe system 10 by a user. It should be understood that an air pressuresensor (not shown) associated with the air purifier 14 may also be usedto measure increases in pressure which correlate to air cleaning elementcontamination. In general, the air purifier 14 is near a door D in theat least one room or environment 12 where the air purifier 14 is coupledto a power source and operated in the at least one room or environment12 in order to purify the air therein.

As will be described later herein, one advantage of the system 10 andmethod described herein is that it is adapted to maintain, monitor andimprove the air quality by automatically reordering the air cleaningelement 16, suggested actions such as air cleaning element cleaning, aircleaning element replacement or providing information that will permit auser to order and/or replace the air cleaning element 16 in a timelymanner.

Advantageously, the system 10 and method is adapted to collect clinicaland physical data and parameters 18 which will be described in moredetail later herein. The system 10 also generates physical data andparameters 19 associated with the at least one room or environment 12.The clinical and physical data and parameters 18 are illustrated in FIG.1 and include various parameters or information relating to the patientP or procedure, such as patient information and/or identification codesassociated with the patient P, a patient’s diagnosis and/or patientlocation identification (e.g., if the patient in a patient room or in anoperating room). The clinical and physical data and parameters 18further include the clinical event type, such as a brain surgery, openheart surgery or other procedure. The clinical and physical data andparameters 18 further comprise clinical event length and clinical eventtime associated with the clinical event type.

In the illustration being described, the system 10 is adapted to receivethat information from at least one input terminal 20 that a user may useto input the clinical and physical data and parameters 18 into aninventory and data collection system (IDCS) 22. The input terminal 20provides input means 24 for inputting the clinical and physical data andparameters 18 to allow for automatic and/or user input of the clinicaland physical data and parameters 18.

The system 10 and method are also adapted for generating, sensing andreceiving the physical data and parameters 19 associated with the atleast one room or environment 12. In the illustration being described,the physical data and parameters 19 include, for example, airparticulate levels in the at least one room or environment 12, airquality, temperature, humidity, air purifier functionality, ultravioletoutput, air cleaning element condition, air cleaning elementidentification codes, air purifier identification codes or otherinformation regarding either the air purifier 14 or the at least oneroom or environment 12. The physical data and parameters 19 aregenerated by at least one or a plurality of sensors 26 associated withat least one of the air purifier 14 and the at least one room orenvironment 12. The at least one or a plurality of sensors 26 maycomprise an air particulate sensor (FIG. 3 ) which measures the count ormass of particulates in the at least one room or environment 12. In themost common embodiment, the at least one or a plurality of sensors 26contains a small fan 26 a to draw in air and a low-power laser 26 b thatgenerates a beam 26 b 1 which is interrupted by particulate matter PM.The amount of laser interruption is detected by an optical sensor 26 c,and air particulate levels are calculated in a manner conventionallyknown.

Contamination of the air cleaning element 16 can also be detected by aninternal pressure sensor (not shown) in the air purifier 14. If the aircleaning element 16 becomes obstructed with debris, internal pressureswill rise which can be logged by the system 10.

For example, a humidity and temperature sensor may be used to provide atemperature and humidity measurement. The system 10 may also comprisethe least one or a plurality of sensors 26 associated with the airpurifier 14 and adapted to provide sensed information regarding the airpurifier 14. For example, the sensed information may include whether ornot the air purifier 14 is functioning properly, the ultraviolet outputof the air purifier 14, a level of contamination of the air cleaningelement 16 and an air cleaning element identification code and/or an airpurifier identification code which can help in maintaining the airpurifier 14 and/or replacing one or more air cleaning elements 16 orother components of the air purifier 14.

Advantageously, the at least one sensor 26 may comprise an airparticulate sensor for sensing the particulates and contamination in theair in the at least one room or environment 12. It should also beunderstood that these inputs may be user generated and input into theinventory and data collection system 22 using at least one or aplurality of terminals, such as the input terminal 20 illustrated inFIG. 1 . The at least one sensor 26 or the input means or input terminal20 may incorporate at least one of sensors, keyboard, touch screen,remote signal, radio frequency identification or similar means adaptedto create, sense or input the physical data and parameters 19 into theinventory and data collection system 22.

Note that the system 10 further comprises data storage or storage means28, such as a server, for storing the clinical and physical data andparameters 18 as well as the physical data and parameters 19 andoutputs. In the illustration being described, the storage means 28 couldcomprise magnetic, solid state, cloud storage, such as on a server overthe internet, or other equivalent data storage methodologies that may beoperating at the location where the at least one room or environment 12is located or could be at a remote location. It should be understoodthat the various inputs, the user input of the clinical and physicaldata and parameters 18 or sensed inputs of the physical data andparameters 19, are either sensed by the at least one sensor 26 orotherwise input into the system 10 and stored on the storage means 28.

Advantageously, the inventory and data collection system (IDCS) 22comprises means to record, output (hard copy or electronic) and/ordisplay the clinical and physical data and parameters 18 as well as thephysical data and parameters 19 substantially contemporaneously to, forexample, allow for a user or system to readily evaluate the relationshipbetween or among a plurality of the clinical and physical data andparameters 18 and/or the physical data and parameters 19. The inventoryand data collection system 22 is adapted to output data via an output oroutput means 30 to allow for a user to display, print, store, network ormonitor the clinical and physical data and parameters 18 as well as thephysical data and parameters 19. In the illustration being described,the output means 30 comprises a visual, printed or electronic outputsfor local or remote monitoring of the patient P and/or the at least oneroom or environment 12. The information and data is output at block 32as illustrated in FIG. 1 and ultimately displayed on a terminal 34,printed on a printer 36 and/or used to perform some other action 40,such as generating an audio or visual alarm 38. The actions 40 are aresult of analyzing and comparing the information gathered in theinventory and data collection system 22. The actions 40 may include, butare not limited to the following:

-   Research (e.g., infection rates versus room air quality)-   Air quality control-   Room contamination evaluation and remediation-   Air purifier monitoring-   Air cleaning element quality-   Air cleaning element reorder-   Air cleaning element replacement-   Air cleaning element cleaning-   Room condition sensing    -   Temperature    -   Humidity    -   Air quality-   Record retention of air quality and room conditions-   Alarm-   Investigation of issues

One important aspect of the system 10 and method found by the inventoris that the system 10 and method permit research to hopefully reduceinfection rates in patients P. For example, the inventory and datacollection system 22 or a user may find a correlation between patientinfection rates in a particular room or environment 12 of a hospital anda particular type of clinical procedure. For example, during an openheart surgery or brain surgery for a patient P who obtained an infectionit may be determined that during that procedure the temperature washigher than normal and with the ultraviolet output of the air purifier14 being at an undesirable level or it may be determined that thecondition of the air cleaning element 16 during that procedure had anundesirable amount of contamination, even though, for example, the aircleaning element was not due for replacement at the time.

Advantageously, the system 10 and method may provide a correlationbetween one or more clinical and physical data and parameters 18 and thephysical data and parameters 19 associated with the at least one room orenvironment 12. Some other examples of the research can be investigatingpatterns of air contamination during a medical procedure, determiningcorrelation between air quality and infection rates or other clinicaloutcomes, or evaluating the effectiveness of the system 10 and methodfor the at least one room or environment 12. The system 10 providespreviously unknown means and apparatus for gathering and interpretingdata.

Another advantageous feature of the system 10 and method is that itprovides for ordering and/or automatic reordering of the air cleaningelement 16 used in the air purifier 14 in response to at least one ofthe clinical and physical data and parameters 18 or the physical dataand parameters 19 sensed or an evaluation of such information and data.Once the outputs 30 are generated, it may be determined that one or moreactions 40 need to be taken and these actions 40 may be automated ormanual. For example, the action of reordering the air cleaning element16 for the air purifier 14 may be done either manually by a user or thesystem 10 may automatically generate a purchase order (not shown) whichis submitted to an air cleaning element supplier in order to reorder andobtain a new air cleaning element 16 for the air purifier 14.Alternatively, it may be determined that the humidity or temperatureneeds to be raised or lowered in the at least one room or environment 12for optimal care of the patient P and, most importantly, for reducing oreliminating unwanted airborne contamination in the at least one room orenvironment 12.

Referring now to FIG. 2 , a schematic is shown of the system 10illustrating one embodiment of a procedure or a methodology inaccordance with one embodiment of the invention being described. Theprocedure or method starts at block 50 wherein the user inputs theclinical and physical data and parameters 18 into the inventory and datacollection system 22 using the input means, such as the input terminal20. The routine proceeds to block 52 wherein the physical data andparameters 19 described earlier herein are input or sensed and inputinto the inventory and data collection system 22.

At block 54, the routine proceeds with the inventory and data collectionsystem 22 and/or the user evaluates and compares the clinical andphysical data and parameters 18 and evaluates relationships between oramong the clinical and physical data and parameters 18 and the physicaldata and parameters 19. At block 56, the output means 30 allows for theuser to display, print, store, network or monitor the clinical andphysical data and parameters 18. For example, the output means 30 maygenerate a visual report for display on the input terminal 20 or aprinted report or form or other output for local or remote monitoring.Although not shown, the various data and information generated orreceived at blocks 50-57 may be stored on the server or storage means 28mentioned earlier herein, but which is not shown in FIG. 2 for ease ofillustration. At block 57, the clinical and physical data and parameters18 and the physical data and parameters 19 are evaluated and comparedbefore preceding to block 58. It is determined at decision block 58whether any actions are required or necessary. If no actions arerequired or necessary, then the routine proceeds back to block 50 asshown.

If actions are necessary, as determined by the user or the inventory anddata collection system 22, then one or more actions are performed atblock 60. In this regard, the actions may include at least one or aplurality of the following:

-   Research (e.g., infection rates versus room air quality)-   Air quality control-   Room contamination evaluation and remediation-   Air purifier monitoring-   Air cleaning element quality-   Air cleaning element reorder-   Air cleaning element replacement-   Air cleaning element cleaning-   Room condition sensing    -   o Temperature    -   o Humidity    -   o Air quality-   Record retention of air quality and room conditions-   Alarm-   Investigation of issues

Although not shown, the inventory and data collection system 22 maycomprise a microprocessor (not shown) programmed to control theoperation of the inventory and data collection system 22 and to performone or more of the actions mentioned earlier relative to block 60. Theprocessor may have at least one or a plurality of lookup tables storedin suitable memory or storage means 28 that correlates predeterminedconditions with the actions to be taken. The following table isillustrative of some of the correlations:

INPUT OF SENSED INFORMATION BY USER INPUTS 24 OR SENSOR INPUTS 26ACTION(S) Unreasonably high contamination sensed in operating room orenvironment 12 • Generate alarm 38, check air cleaning element 16,generate warning notice or alarm of unreasonably high contaminate levelAt least one sensor 26 senses that air cleaning element 16 is eitheroverloaded with contaminates or it is close to being over contaminated(e.g., it is anticipated that the air cleaning element 16 becomesoverloaded during a surgical procedure) • Automatic reordering of aircleaning element 16 from supplier • Replace air cleaning element 16 oncereceived • Alternatively, an automatic call to a service technician toservice the air purifier 14 User compares contaminate particulate levelfrom the physical data and parameters 19 to the patient’s diagnosis andthe type of clinical event time and determines that, again, the aircleaning element 16 needs to be replaced. • User orders and/or replacesair cleaning element 16 manually or contacts a technician to service theair purifier 14 in order to improve the air purity and quality in the atleast one room or environment 12 Evaluation of the air cleaning element16 and any contamination level • If contamination is determined from theat least one of a comparison of the clinical and physical data andparameters 18 and the physical data and parameters 19, then the system10 may generate through the output or output means 30 an audio or visualalarm 38 to replace the air cleaning element 16 or service the airpurifier 14. A clinical procedure is being performed or has beencompleted, with input of procedure information, via manual entry,networked data, or visual sensors which can detect a discrete procedure• A clinical event is logged in the system’s 10 memory, a newsingle-procedure air cleaning element 16 is ordered or marked for orderin a printed, displayed or transmitted manner. A number of clinicalprocedures are being performed or have been completed, with input ofprocedure information, via manual entry, networked data, or visualsensors which can detect discrete procedures. • The clinical events,either grouped or individually, are logged in the system’s 10 memory, anew multi-procedure air cleaning element 16 or group of single-procedureair cleaning elements 16 are ordered or marked for order in a printed,displayed, or transmitted manner.

Advantageously, the system 10 and method provide the followingadvantages:

-   Air purifier 14 service and/or replacement of air cleaning element    16.-   Automated reordering of a used air cleaning element 16.-   Improved air quality in the at least one room or environment 12.-   Decrease in the infection rates of patients P as a result of air    contamination in the at least one room or environment 12.-   Providing an improved system 10 and method which is adapted to    maintain an appropriate level of replacement air cleaning elements    16 and parts for the air purifier 14 in response to at least one of    the clinical and physical data and parameters 18 or the physical    data and parameters 19.-   Ability to track air quality in the at least one room or environment    12.-   Ability to track compliance with usage of the system 10.-   Ability to monitor the performance of the system 10, either locally    or remotely.-   Evaluation of clinical and physical data for a room, such as an    operating room, to provide a whole picture.-   The system 10 and air purifier 14 with air cleaning element 16 may    be used in an operating room or other room to reduce infectious    biological debris from spreading contamination to the patient P or    from one procedure for a first patient P to a second patient P    during another procedure. In other words, the system 10 and method    reduce the spread of contamination by enabling a user to understand    the source of the contamination using the physical data and    parameters 19 and also improving the efficiency of the air purifier    14 by, for example, replacing or cleaning of the air cleaning    element 16. As mentioned earlier herein, this air cleaning element    reordering and/or replacement may be preemptive or at a time when    normal circumstances would suggest to the user that an air cleaning    element replacement is not necessary.-   The embodiments being described provide a system 10 and method for    purifying operating room air which allows each surgical procedure to    have a non-contaminated air purifier 14 to prevent the spread of    bacterial contamination. Thus, for example, if the at least one    sensor 26 associated with the air purifier 14 senses any    contamination of the air cleaning element 16, then the system 10    and/or an inventory and data collection system (IDCS) 22 may call    for an immediate replacement of the air cleaning element 16, even if    it does not have many hours of use. Alternatively, it is also    contemplated that the system 10 and method could cause a    notification, reorder and replacement of an air cleaning element 16    if, for example, the contamination of the air cleaning element 16 is    sensed to be greater than 1.5 in H₂0 internal air pressure which can    be done by three illustrative ways: a predetermined elapse of time    since the air cleaning element 16 was last changed, increased    pressure inside the system 10 via the pressure sensor mentioned    earlier, or increases of air contamination in the at least one room    or environment 12 indicating that adequate cleaning is not being    performed.-   One feature, as mentioned in earlier herein, could be a camera C    (FIG. 1 ) built into the system 10 which would detect clinical    events, such as surgeries. An algorithm or artificial intelligence    is store in memory of the inventory and data collection system    (IDCS) 22 to determine when a procedure has been completed, and this    information could be incorporated into the database for usage    tracking/ordering of the air cleaning element 16 and the like. This    could also be used to determine the number of occupants in the at    least one room or environment 12, which is important in evaluating    air quality.-   The at least one sensor 26 may also comprise another sensor which    could be added to the system 10 is an external air pressure sensor    (not shown). This would measure the number of time the door D in an    operating room (which is slightly pressurized) has opened. This is    an important data input in evaluating air quality.-   An internal air pressure sensor which could be used to determine    abnormalities in the function of the system 10. Readings too high    could indicate an obstructed outflow, too low inflow, etc. Again    this would be incorporated into the logging/transmitting/alarm ing    process.-   One embodiment of the invention may comprise a system for    maintaining or monitoring at least one environment having at least    one air purifier, the system comprising at least one first input or    input means for a user to input at least one of clinical data or    physical parameters into a collection system, at least one second    input or sensor associated with the environment for collecting    physical data regarding the environment and for inputting it into    the collection system, at least one output for outputting the at    least one of clinical or physical parameters and the physical data,    at least one element that uses and processes the at least one of    clinical or physical parameters and the physical data in a    predetermined format as input from the at least one first input and    the at least one second input, respectively, and outputs integrated    information, and the system being adapted to permit a user to use    such integrated information to at least one of maintain or improve    the at least one of the environment or take at least one action in    response to the integrated information, the integrated information    being adapted or used for at least one of research, improving air    quality, quality review of the environment or control or    notification of at least one issue associated with the environment    or the integrated information.-   Another embodiment of the invention may comprise a system for    improving air quality in at least one hospital room or operating    room, the system comprising at least one first input or sensor for    inputting for a user to input at least one of clinical data or    physical parameters into a collection system, at least one second    input or sensor associated with an environment for collecting    physical data regarding the environment and for inputting it into    the collection system, at least one output for outputting the at    least one of clinical or physical parameters and the physical data,    at least one element that uses and processes the at least one of    clinical or physical parameters and the physical data as input from    the at least one first input and the at least one second input,    respectively, and outputs integrated information, and the system    being adapted to permit use of such integrated information to take    at least one action that at least one of maintains or improves the    air quality.-   Another embodiment of the invention may comprise a method for    maintaining or monitoring at least one environment having at least    one air purifier, the method comprising the steps of inputting at    least one clinical data or physical parameters into a collection    system, sensing physical data regarding the at least one environment    and for inputting it into the collection system, outputting from the    collection system at least one output generated using the at least    one of clinical or physical parameters and the physical data, using    at least one element to process the at least one of clinical or    physical parameters and the physical data as input from at least one    first input and at least one second input, respectively, and outputs    integrated information in response thereto, and using such    integrated information to at least one of maintain or improve the at    least one of the environment or take at least one action in response    to the integrated information, the integrated information being    adapted or used for at least one of research, improving air quality,    quality review of the environment or control or notification of at    least one issue associated with the environment or the integrated    information.-   Still another embodiment of the invention may comprise an inventory    system for supporting the purifying of operating room air on a    per-patient basis consisting of a record of patient identifying    information, a record describing an air cleaning element utilized in    an air purifier located in an operating room, the air cleaning    element being used for an individual patient procedure, the record    describing the air cleaning element comprising manufacturer name,    part number, and/or serial number in association with the patient    identifying information, the inventory system adapted to facilitate    inventory actions such as re-ordering, replacement, recordkeeping,    invoicing and/or billing of the air cleaning element, the inventory    system associating the inventory actions to the patient identifying    information.-   Still another embodiment of the invention may comprise a method of    purifying operating room air comprising activating a portable air    purifier, after a surgical procedure, removing a contaminated air    cleaning element from the air purifier, recording data regarding the    air cleaning element to effect remuneration or recordkeeping by    hospital, air cleaning element manufacturer, patient, or related    payor in electronic or paper medical record or related document,    replacing the air cleaning element with new air cleaning element.-   Another embodiment of the invention may comprise a method of    purifying operating room air comprising locating an area of an    operating room which has the highest amount of human traffic/and or    airborne contamination, positioning an air purifier proximate to the    area, the air purifier having an air cleaning element, after a    surgical procedure, removing a contaminated air cleaning element    from the air purifier, recording data regarding the air cleaning    element to effect remuneration or recordkeeping by hospital, air    cleaning element manufacturer, patient, or related payor in    electronic or paper medical record or related document, replacing    the air cleaning element with new air cleaning element.-   Another embodiment of the invention may comprise a method of    purifying operating room air comprising positioning an air purifier    adjacent to an operating room door, instrument table or patient    table, the air purifier having an air cleaning element, after a    surgical procedure, removing a contaminated air cleaning element    from the air purifier, recording data regarding the air cleaning    element to effect remuneration or recordkeeping by hospital, air    cleaning element manufacturer, patient, or related payor in    electronic or paper medical record or related document, replacing    the air cleaning element with new air cleaning element.-   Another embodiment of the invention may comprise a method of    purifying operating room air comprising placing an air purifier, the    air purifier having means for direct bacterial deactivation, such as    irradiation, chemical oxidation, or ionization, and an air cleaning    element, after a surgical procedure, removing a contaminated air    cleaning element from the air purifier, recording data regarding the    air cleaning element to effect remuneration or recordkeeping by    hospital, air cleaning element manufacturer, patient, or related    payor in electronic or paper medical record or related document,    replacing the air cleaning element with new air cleaning element.-   Another embodiment of the invention may comprise a method of    purifying operating room air comprising placing an air purifier, the    air purifier having means for air quality monitoring and an air    cleaning element, after a surgical procedure, removing a    contaminated air cleaning element from the air purifier, recording    data regarding the air cleaning element to effect remuneration or    recordkeeping by hospital, air cleaning element manufacturer,    patient, or related payor in electronic or paper medical record or    related document, recording data regarding air quality information    in a patient record or related record, replacing the air cleaning    element with new air cleaning element.-   Another embodiment of the invention may comprise a method for    providing an air purifier for operating room use the purifier    provided to the hospital or surgical facility at no cost or for    materially less than the typical purchase cost of comparable    product, the purifier containing an interchangeable air cleaning    element, the air cleaning element changed on a per patient basis,    the hospital or surgical facility, patient, payor or related party,    paying for the air cleaning element on a per-patient basis, revenue    from the air cleaning element usage offsetting cost of the purifier.-   Another embodiment of the invention may comprise an inventory and    data collection system, operative with an air purification device,    for the purpose of recording and integration of data regarding    physical parameters and clinical parameters within a clinical    situation.

Advantageously, the embodiments shown and described herein could be usedalone or together and/or in combination with one or more of the featurescovered by one or more of the claims set forth herein, including but notlimited to one or more of the features or steps mentioned in the Summaryof the Invention and the claims.

While the system, apparatus and method herein described constitutepreferred embodiments of this invention, it is to be understood that theinvention is not limited to this precise system, apparatus and method,and that changes may be made therein without departing from the scope ofthe invention which is defined in the appended claims.

1. A system for maintaining or monitoring at least one environmenthaving at least one air purifier, said system comprising: at least onefirst input or input means for a user to input at least one of clinicaldata or physical parameters into a collection system; at least onesecond input or sensor associated with said environment for collectingphysical data regarding the environment and for inputting it into saidcollection system; at least one output for outputting said at least oneof clinical or physical parameters and said physical data; at least oneelement that uses and processes said at least one of clinical orphysical parameters and said physical data in a predetermined format asinput from said at least one first input and said at least one secondinput, respectively, and outputs integrated information; and said systembeing adapted to permit a user to use such integrated information to atleast one of maintain or improve said at least one of said environmentor take at least one action in response to said integrated information;said integrated information being adapted or used for at least one ofresearch, improving air quality, quality review of said environment orcontrol or notification of at least one issue associated with saidenvironment or said integrated information.
 2. The system as recited inclaim 1 wherein said at least one action is a service of said airpurifier.
 3. The system as recited in claim 2 wherein said service ischanging an air cleaning element in said air purifier.
 4. The system asrecited in claim 1 wherein said at least one action is automaticallycontrolling operation of said air purifier in said at least oneenvironment in response to said integrated information.
 5. The system asrecited in claim 1 wherein said at least one action is using saidintegrated information for at least one of research, evaluation of airparticulate levels, or providing a condition of said at least oneenvironment.
 6. The system as recited in claim 5 wherein said conditionof said at least one environment is at least one of air particulatelevel, contamination level, cleanliness, temperature, humidity or airquality.
 7. The system as recited in claim 1 wherein said at least oneenvironment is a room where a patient is located.
 8. The system asrecited in claim 1 wherein said at least one environment is an operatingroom.
 9. The system as recited in claim 1 wherein said clinical data isat least one of patient information and/or identification codes,diagnosis, location identification, clinical event type, clinical eventlength or clinical event time.
 10. The system as recited in claim 1wherein said physical data is at least one of air particulate levels,air quality, temperature, humidity, air purifier functionality,ultraviolet output, air cleaning element condition, air cleaning elementidentification codes or air purifier identification codes.
 11. Thesystem as recited in claim 1 wherein said at least one action includesat least one of research, air quality control, room contaminationevaluation and remediation, air purifier monitoring, air cleaningelement quality, air cleaning element reorder, air cleaning elementreplacement, air cleaning element cleaning, room condition sensingtemperature, humidity and/or air quality, record retention of airquality and room conditions, alarm and/or investigation of issues. 12.The system as recited in claim 1 wherein said at least one sensorcomprises at least one of an air particle sensor, an optical sensor, aninternal pressure sensor, a humidity sensory and/or a temperaturesensor.
 13. The system as recited in claim 1 wherein said air cleaningelement may be one of a filter, an electrostatic screen, an ultravioletlight or the like.
 14. A system for improving air quality in at leastone hospital room or operating room, said system comprising: at leastone first input or sensor for inputting for a user to input at least oneof clinical data or physical parameters into a collection system; atleast one second input or sensor associated with an environment forcollecting physical data regarding said environment and for inputting itinto said collection system; at least one output for outputting said atleast one of clinical or physical parameters and said physical data; atleast one element that uses and processes said at least one of clinicalor physical parameters and said physical data as input from said atleast one first input and said at least one second input, respectively,and outputs integrated information; and said system being adapted topermit use of such integrated information to take at least one actionthat at least one of maintains or improves the air quality.
 15. Thesystem as recited in claim 14 wherein said at least one action is aservice of an air purifier.
 16. The system as recited in claim 15wherein said service is re-ordering a replacement air cleaning elementfor said air purifier.
 17. The system as recited in claim 15 whereinsaid service is changing an air cleaning element in said air purifier.18. The system as recited in claim 14 wherein said at least one actionis automatically controlling operation of an air purifier in said atleast one hospital room or operating room in response to said integratedinformation.
 19. The system as recited in claim 14 wherein said at leastone action is using said integrated information for at least one ofresearch, evaluation of air particulate levels, or providing a conditionof said at least one hospital room or operating room. 20-23. (canceled)24. A method for maintaining or monitoring at least one environmenthaving at least one air purifier, said method comprising the steps of:inputting at least one clinical data or physical parameters into acollection system; sensing physical data regarding the at least oneenvironment and for inputting it into said collection system; outputtingfrom said collection system at least one output generated using said atleast one of clinical or physical parameters and said physical data;using at least one element to process said at least one of clinical orphysical parameters and said physical data as input from at least onefirst input and at least one second input, respectively, and outputsintegrated information in response thereto; and using such integratedinformation to at least one of maintain or improve said at least one ofsaid environment or take at least one action in response to saidintegrated information; said integrated information being adapted orused for at least one of research, improving air quality, quality reviewof said environment or control or notification of at least one issueassociated with said environment or said integrated information. 25-64.(canceled)